K250897
- 510(k) number
- K250897
- Device name
- Koala Intrauterine Pressure Catheter (IPC-5000E)
- Applicant
- Clinical Innovations, LLC UT · US
- Product code
- HFN — Transducer, Pressure, Intrauterine
- Decision date
- 2025-05-22
- Date received
- 2025-03-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
510(k) Summary (official FDA PDF): K250897.pdf
Official FDA record: K250897
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.